Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia

Daniel Stephan Engeler

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: Prostatic artery embolization; Procedure: monopolar transurethral prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02054013

CTU 13.030

Details and patient eligibility

About

Benign prostatic hyperplasia (BPH) is a prevalent entity, affecting over 50% of men older than 60 years. The clinical picture of the disease includes lower urinary tract symptoms such as interrupted and weak urinary stream, nocturia, urgency and leaking and even sexual dysfunction in some individuals. Medical therapy is usually the first-line treatment. However, the efficacy of drugs like alpha-blockers is limited, and as disease progresses more invasive treatment options have to be taken into consideration. In cases with moderate to severe lower urinary tract symptoms (LUTS) transurethral resection of the prostate (TUR-P) is the standard treatment. TURP, however, is limited to prostates smaller than 60-80ml and the procedure is associated with a complication rate. The cumulative short-term morbidity rate is around 11% and the necessity for surgical revision is as high as 6%. Bleeding requiring transfusions and transurethral resection syndrome represent potentially serious threats to elderly and frail patients. Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure, which can be performed in an outpatient setting with rapid recovery and low morbidity.

The investigators hypothesize that PAE is non-inferior in the treatment of symptomatic BPH compared to conventional and established TUR-P.

Enrollment: 101 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men older than 40
• Patient must be a candidate for TURP
• Refractory to medical therapy or patient is not willing to consider (further) medical treatment
• Patient has a prostate size of at least 25 ml and not more than 80 ml, measured by ultrasound
• IPSS ≥8
• QoL ≥3
• Qmax<12 and/or urinary retention
• Written informed consent

Exclusion criteria

• Mild symptoms (IPSS <8)
• Severe atherosclerosis
• Severe tortuosity in the aortic bifurcation or internal iliac arteries
• Acontractile detrusor
• Neurogenic lower urinary tract dysfunction
• Urethral stenosis
• Bladder diverticulum
• Bladder stone with surgical indication
• Allergy to intravenous contrast media
• Contraindication for MRI imaging
• Preinterventionally proven adenocarcinoma of the prostate
• Renal failure (GFR<60ml/min)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Prostatic artery embolization

Experimental group

Description:

Prostatic artery embolization (PAE) has been suggested as a minimal invasive alternative procedure with rapid recovery and low morbidity

Treatment:

Procedure: Prostatic artery embolization

Conventional monopolar transurethral prostatectomy

Other group

Description:

Standard treatment

Treatment:

Procedure: monopolar transurethral prostatectomy